A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI

University of Louisville (UOFL)

Status: Enrolling

Conditions: Myocardial Injury

Treatments: Radiation: CCTA scan

Study type: Observational

Funder types: Other

Identifiers

NCT06382402

23.0924

Details and patient eligibility

About

This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI.

Full description

This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. Patients are randomized into 2 groups. Group 1 undergoes coronary 64-detector row computed tomography angiography (CCTA) and Group 2 receives conservative management and treatment for underlying conditions. The investigators will evaluate cross-sectional and time-varying clinical, laboratory, and imaging characteristics in association with clinical events. The exclusion criteria are an absence of information for follow-up of clinical events, and patients who have absolute and relative contraindications for CCTA. Absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast, inability to cooperate with scan protocols, hemodynamic instability, decompensated heart failure, acute myocardial infarction, and renal impairment with GFR < 30. Relative contraindications include pregnancy, inability to tolerate heart rate-slowing medications or nitroglycerin, recent phosphodiesterase inhibitor use, severe aortic stenosis, bronchospastic disease, and patient's weight and height.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatient with type 2 NSTEMI
• Aged 18-70 years old
• At the University of Louisville and Jewish hospitals

Exclusion criteria

• History of severe or anaphylactic reaction to iodinated contrast
• Inability to cooperate with scan protocols
• Hemodynamic instability
• Decompensated heart failure
• Acute myocardial infarction
• Renal impairment with GFR < 30
• Pregnancy
• Inability to tolerate heart rate-slowing medications or nitroglycerin
• Recent phosphodiesterase inhibitor use
• Severe aortic stenosis
• Bronchospastic disease
• Patient's weight and height

Trial design

700 participants in 2 patient groups

CCTA Group

Description:

CT group will undergo CCTA to evaluate for coronary artery disease to early address underlying CAD and then care will be directed based on the findings of that CT scan.

Treatment:

Radiation: CCTA scan

No CCTA Group

Description:

Group 2 will not undergo CCTA and will be managed at the discretion of the primary team using the standard of care pathway comprising of either conservative medical management, stress testing, or invasive evaluation with coronary angiography in the catheterization laboratory.